ohnson & Johnson will soon start testing a vaccine the world badly needs — one that protects against the worst strains of Ebola and its very dangerous cousin, the Marburg virus.
Although there are currently no licensed Ebola vaccines on the market anywhere, J&J’s subsidiary, Janssen Vaccines and Prevention BV, is working on a second-generation product, which would provide protection against three killer viruses.
The start of the so-called Phase 1 trial — the first stage of testing in people — was announced Monday in a statement from the company. A spokesperson said screening of volunteers began late last week in Rockville, Md., where the trial will be conducted.
Phase 1 trials are small, designed to see if an experimental vaccine is safe to use in people and how much vaccine is needed to form an effective dose.
The vaccine is a multivalent — multiple vaccines in one. It is designed to protect against Ebola Zaire — the strain that caused the massive West African outbreak — and Ebola Sudan, a slightly less frequently seen, but almost as deadly, strain, and the related Marburg virus.
The vaccine, if effective, would be given in two doses, one to prime the immune system to recognize these dangerous invaders, and a booster shot of a different vaccine that would amplify the immune response.
It is thought a two-shot regimen would provide more long-lived protection than a vaccine that is given in a single injection.
The priming dose vaccine was created through a collaboration between Janssen and the National Institute of Allergy and Infectious Diseases. The booster shot was developed by Bavarian Nordic A/S.
Having a vaccine that would protect against multiple viral hemorrhagic fever threats is a cherished goal of emergency response planners, who wouldn’t have to worry about keeping supplies of three separate vaccines in emergency stockpiles.
A number of research institutes have been working for years on Ebola vaccines, but the candidate vaccines languished because there was no commercial interest in developing them. However, during the summer and autumn of 2014, when Ebola ravaged Guinea, Sierra Leone, and Liberia, a number of companies, including J&J, joined the pursuit.
Only one vaccine, designed at Canada’s National Microbiology Laboratory and licensed to Merck, has been tested in people to see if it is protective. It was highly protective, and Merck has said it will file licensure applications for the vaccine by the end of 2017.
In the meantime, the company has applied to the World Health Organization for inclusion in the WHO’s Emergency Use Assessment and Listing procedure, which would allow the vaccine to be used in future outbreaks. That application was filed in December but to date there hasn’t been a ruling from the WHO.
J&J announced Monday that it, too, is seeking an EUAL designation for its Ebola Zaire vaccine, which has completed Phase 1 testing, but was not tested for efficacy because the West African outbreak ended before that work could be done.
“We must take action now so that a tragedy on the scale of West Africa never happens again,” said Dr. Paul Stoffels, J&J’s chief scientific officer.
“Having an Ebola vaccine available is critical for global preparedness. If the WHO grants an emergency use listing, this will accelerate the availability of Janssen’s investigational vaccine regimen to the international community in the event another Ebola crisis occurs.”